FDA issues new guidance to food industry amid recall criticism

The US Food and Drug Administration issued ...

Posted: Jan. 4, 2018 5:43 PM

Updated: Jan. 5, 2018 10:15 AM

The US Food and Drug Administration issued guidance to the food industry Thursday detailing how it plans to enforce the FDA Food Safety Modernization Act, which was signed into law during the Obama administration. The agency characterizes the act, which is intended to make the nation's food supply safer, as "the biggest overhaul in our nation's food safety laws in more than 70 years," shifting the system "from being reactive to preventive."

"We recognize that such a fundamental change in our food safety approach may require adjustments along the way to address issues that had not been previously anticipated," the agency said in a statement. It mentions getting feedback from the food industry and farmers, suggesting that there were challenges following some of the rules.

The newguidance is supposed to give the food industry a road map for the new rules, but it also details parts of the act that the agency does not intend to enforce for now, to allow time to "consider changes or other approaches to address concerns."

Though recalls are almost always voluntary, and it's up to the companies themselves to recall food, the FDA helps monitor the food supply and has the legal tools to aid companies in taking appropriate steps. The FDA also lets the public know about a recall if it is what the agency considers a serious hazard.

Before President Obama signed the Food Safety Modernization Act in 2011, the FDA did not have the authority to issue a mandatory recall. The agency could warn manufacturers or distributors of possible health risks, but ultimately, it was up to food companies to recall tainted products. According to the inspector general, the FDA has used its recall authority only twice.

The inspector general's office said it conducted the new review "to determine whether FDA is fulfilling its responsibility in safeguarding the nation's food supply now that it has mandatory recall authority."

This investigation, which reviewed 30 of 1,557 food recalls between 2012 and 2015, found that the FDA "did not always have an efficient and effective food-recall process that ensured the safety of the nation's food supply."

In these cases, food companies took an average of 57 days to recall items after the FDA learned of the possible health hazards, the report revealed.

In one case, Nutrex Research, a supplement company, did not recall its product until 303 days after receiving a warning letter from the FDA. The company also distributed free samples of the adulterated product for more than eight months after it got the FDA warning letter, according to the inspector general's report.

In a case involving cheese contaminated with listeria, it was 81 days from the date the FDA became aware of the adulterated product to the date Oasis Brands recalled it. At least four people were hospitalized after eating the recalled cheese, and there was one known death reported.

"Our review found that FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls," said report author George Nedder, an auditor with the Office of the Inspector General. "This means that dangerous food products may have remained in our nation's food supply for weeks after FDA was aware of the contamination."

"In one case, a baby died, and nine others became ill, all from consuming cheese that contained listeria," Nedder added, referring to the Oasis Brands recall.

Dr. Scott Gottlieb, the FDA's commissioner, agreed with the findings and said "immediate action" needed to be taken.

"I take these obligations very seriously," Gottlieb said in a December 26 statement. "Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities -- and how we deploy them -- are a cornerstone of our vital, consumer protection mission."

Luke LaBorde, a professor of food science at Pennsylvania State University, said the FDA has to consider what's at stake when making a recall decision.

"They're trying to walk a fine line," said LaBorde, who was not involved in the investigation. "They don't want to be too fast on the trigger, because they've been burned in the past on issuing recalls. It's a huge economic effect on an industry. It could wipe them out. But on the other hand, if people start dying, that's even worse than the recall."

In several incidents, like the listeria cheese outbreak, the FDA struggled to evaluate health risks in a timely manner or ensure that companies initiated recalls quickly, according to the report.

Many of the procedural problems presented in the new report were also raised by the inspector general in a preliminary audit published in 2016. The FDA responded by creating a team called Strategic Coordinated Oversight of Recall Execution, or SCORE. It investigates cases that pose a significant health hazard to consumers and expedites the decision-making process.

In the new report, the inspector general's recommendations included that the FDA use its SCORE initiative "to establish set timeframes, expedite decision-making and move recall cases forward and improve electronic recall data."